MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POLY RADPICC 5F DUAL-LUMEN POLYURETHANE CATHETER BASIC KIT; IMPLANTED, LONG TERM INTRAVASCULAR CATHETERS

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reax0096 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
Facility reported that prior to use, the healthcare professional was unable to flush the catheter.A new device was opened to complete the procedure.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a that the catheter could not be flushed prior to use was confirmed, and the cause was determined to be manufacturing related.One 5fr d/l poly radpicc was returned for investigation.The product appeared to be unused.The d/l tubing had not been trimmed to length.Functional testing confirmed that the gray lumen could not be flushed.After dissecting the catheter, material from the bifurcation molding process was observed within the gray lumen at the same point as the wings.The complaint sample was forwarded to the manufacturing facility for further review.Reynosa evaluation: the complaint of ¿occlusion¿ is confirmed as manufacturing related, due to it was occluded with resin.Visual inspection found resin on the bifurcation area.

• Brand Name: POLY RADPICC 5F DUAL-LUMEN POLYURETHANE CATHETER BASIC KIT
• Common Device Name: IMPLANTED, LONG TERM INTRAVASCULAR CATHETERS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6472516
• Report Number: 3006260740-2017-00370
• Device Sequence Number: 850042
• Product Code: LJS
• UDI-Device Identifier: 00801741035111
• UDI-Public: (01)00801741035111(17)191031(10)REAX0096
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K034019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 3265155
• Device Lot Number: REAX0096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2017
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/23/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/07/2017
• Supplement Report FDA Received Date: 06/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1